510(k) · Cleared
ClearedSuretek Medical Reprocessed Electrosurgical Electrodes
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Suretek Medical · NUJ Electrosurgical, Cutting & Coagulation Accessories, Laparoscopic & Endoscopic, Reprocessed
Cleared on May 10, 2006 as substantially equivalent to K033257 (Arthrocare Corp., 2003) and 10 other predicates after a 224-day review. Its family tree reaches back 10 generations to 1994.
- Decided
- May 10, 2006
- Review
- 224 days
- Class
- Class II
- Product code
- NUJ
- Recalls
- None
- Predicates
- 11
Its longest line of descent runs back 10 generations to K936109 (1994). 93 ancestors in all, the oldest K800617 (1980). No later device cites it as a predicate yet.
- Root · 10 generations backK936109 Sharplan Model 1120 CO2 Surgical LaserSharplan Lasers, Inc. · 1994
- 6 generations between
- 3 generations backK021364 Modification to Entec Plasma WandsArthrocare Corp. · 2002
- 2 generations backK030108 Arthrocare Ent Coblator Surgery SystemArthrocare Corp. · 2003 · Recalled
- 1 generation backK033257 Arthrocare Ent Plasma WandsArthrocare Corp. · 2003
- This deviceK052692 Suretek Medical Reprocessed Electrosurgical ElectrodesSuretek Medical · 2006
Show all 10 generations
- Root · 10 generations backK936109 Sharplan Model 1120 CO2 Surgical LaserSharplan Lasers, Inc. · 1994
- 9 generations backK960521 Sharplan Lasers, Inc. Silktouch Flash ScannerSharplan Lasers, Inc. · 1996
- 8 generations backK963339 Coherent Ultrapulse CO2 Surgical LasersCoherent Medical Group · 1997
- 7 generations backK974789 Coherent Ultrapulse S Series CO2 Surgical Lasers Model C and LLumenis, Inc. · 1998
- 6 generations backK990947 Modified Versapulse Select Single Wavelength, HO: Yag and Dual…Lumenis, Inc. · 1999
- 5 generations backK011703 Lumenis Versapulse Powersuite Holmium (HO:Yag) and Dual Wavelength…Lumenis · 2001 · Recalled
- 4 generations backK014290 Entec Plasma WandsArthrocare Corp. · 2002
- 3 generations backK021364 Modification to Entec Plasma WandsArthrocare Corp. · 2002
- 2 generations backK030108 Arthrocare Ent Coblator Surgery SystemArthrocare Corp. · 2003 · Recalled
- 1 generation backK033257 Arthrocare Ent Plasma WandsArthrocare Corp. · 2003
- This deviceK052692 Suretek Medical Reprocessed Electrosurgical ElectrodesSuretek Medical · 2006
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K936109 | Sharplan Model 1120 CO2 Surgical Laser | Sharplan Lasers, Inc. | 1994 | — |
| −9 | K960521 | Sharplan Lasers, Inc. Silktouch Flash Scanner | Sharplan Lasers, Inc. | 1996 | — |
| −8 | K963339 | Coherent Ultrapulse CO2 Surgical Lasers | Coherent Medical Group | 1997 | — |
| −7 | K974789 | Coherent Ultrapulse S Series CO2 Surgical Lasers Model C and L | Lumenis, Inc. | 1998 | — |
| −6 | K990947 | Modified Versapulse Select Single Wavelength, HO: Yag and Dual Wavelength, HO… | Lumenis, Inc. | 1999 | — |
| −5 | K011703 | Lumenis Versapulse Powersuite Holmium (HO:Yag) and Dual Wavelength… | Lumenis | 2001 | 2 |
| −4 | K014290 | Entec Plasma Wands | Arthrocare Corp. | 2002 | — |
| −3 | K021364 | Modification to Entec Plasma Wands | Arthrocare Corp. | 2002 | — |
| −2 | K030108 | Arthrocare Ent Coblator Surgery System | Arthrocare Corp. | 2003 | 1 |
| −1 | K033257 | Arthrocare Ent Plasma Wands | Arthrocare Corp. | 2003 | — |
| 0 (this device) | K052692 | Suretek Medical Reprocessed Electrosurgical Electrodes | Suretek Medical | 2006 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1980 | 1 | 0 |
| 1981 | 1 | 0 |
| 1985 | 1 | 0 |
| 1986 | 2 | 0 |
| 1989 | 1 | 0 |
| 1990 | 1 | 0 |
| 1991 | 3 | 0 |
| 1992 | 3 | 0 |
| 1993 | 1 | 0 |
| 1994 | 4 | 0 |
| 1995 | 8 | 0 |
| 1996 | 9 | 0 |
| 1997 | 3 | 0 |
| 1998 | 9 | 0 |
| 1999 | 5 | 0 |
| 2000 | 15 | 0 |
| 2001 | 5 | 0 |
| 2002 | 3 | 0 |
| 2003 | 4 | 0 |
| 2005 | 4 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in NUJ? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new NUJ device
- #1 K220411 Reprocessed LigaSure Curved, Small Jaw, Open…score 8.4 · 8 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (11)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K033257 | Arthrocare Ent Plasma WandsSummary page 1…utting & coagulation accessories, laparoscopic & endoscopic, reprocessed. Manufacturer/Reprocessor Device/System Tradenames 510(k) Arthrocare ArthroWand*, PlasmaWand* K033257, K033584 Mitek VAPR* K963783 Smith & Nephew Vulcan*, Saphyre™ K050898 Linvatec UltrAblator, Lightwave* K030720, K050923 Arthrex… | 2003 |
| * | K033584 | Arthrocare ArthrowandsSummary page 1…coagulation accessories, laparoscopic & endoscopic, reprocessed. Manufacturer/Reprocessor Device/System Tradenames 510(k) Arthrocare ArthroWand*, PlasmaWand* K033257, K033584 Mitek VAPR* K963783 Smith & Nephew Vulcan*, Saphyre™ K050898 Linvatec UltrAblator, Lightwave* K030720, K050923 Arthrex OPES* K0… | 2003 |
| * | K963783 | Mitek Electrosurgical System for Arthroscopic UseSummary page 1…ies, laparoscopic & endoscopic, reprocessed. Manufacturer/Reprocessor Device/System Tradenames 510(k) Arthrocare ArthroWand*, PlasmaWand* K033257, K033584 Mitek VAPR* K963783 Smith & Nephew Vulcan*, Saphyre™ K050898 Linvatec UltrAblator, Lightwave* K030720, K050923 Arthrex OPES* K023986 ValleyLab Elec… | 1996 |
| * | K050898 | Smith & Nephew Vulcan Articular Cartilage Probe, Model 721XXXXSummary page 1…d. Manufacturer/Reprocessor Device/System Tradenames 510(k) Arthrocare ArthroWand*, PlasmaWand* K033257, K033584 Mitek VAPR* K963783 Smith & Nephew Vulcan*, Saphyre™ K050898 Linvatec UltrAblator, Lightwave* K030720, K050923 Arthrex OPES* K023986 ValleyLab Electrosurgical Device K861112,K051627 Vanguar… | 2005 |
| * | K030720 | Ultrablator ElectrodeSummary page 1…m Tradenames 510(k) Arthrocare ArthroWand*, PlasmaWand* K033257, K033584 Mitek VAPR* K963783 Smith & Nephew Vulcan*, Saphyre™ K050898 Linvatec UltrAblator, Lightwave* K030720, K050923 Arthrex OPES* K023986 ValleyLab Electrosurgical Device K861112,K051627 Vanguard Medical Concepts ~ Reprocessed Arthrosco… | 2003 |
| * | K050923 | Lightwave Integrated Electrode Ablator and Light Wave Integrated Electrode Suction AblatorSummary page 1…mes 510(k) Arthrocare ArthroWand*, PlasmaWand* K033257, K033584 Mitek VAPR* K963783 Smith & Nephew Vulcan*, Saphyre™ K050898 Linvatec UltrAblator, Lightwave* K030720, K050923 Arthrex OPES* K023986 ValleyLab Electrosurgical Device K861112,K051627 Vanguard Medical Concepts ~ Reprocessed Arthroscopic Wands… | 2005 |
| * | K023986 | Arthrex Opes Electrodes and AccessoriesSummary page 1…ArthroWand*, PlasmaWand* K033257, K033584 Mitek VAPR* K963783 Smith & Nephew Vulcan*, Saphyre™ K050898 Linvatec UltrAblator, Lightwave* K030720, K050923 Arthrex OPES* K023986 ValleyLab Electrosurgical Device K861112,K051627 Vanguard Medical Concepts ~ Reprocessed Arthroscopic Wands ~ K043198 Alliance M… | 2002 |
| * | K861112 | Model E2517 and Model E2503 Power Control PencilsSummary page 1…4 Mitek VAPR* K963783 Smith & Nephew Vulcan*, Saphyre™ K050898 Linvatec UltrAblator, Lightwave* K030720, K050923 Arthrex OPES* K023986 ValleyLab Electrosurgical Device K861112,K051627 Vanguard Medical Concepts ~ Reprocessed Arthroscopic Wands ~ K043198 Alliance Medical Reprocessed Soft Tissue Ablators ~… | 1986 |
| * | K051627 | Valleylab G3000 Electrosurgical InstrumentSummary page 1…VAPR* K963783 Smith & Nephew Vulcan*, Saphyre™ K050898 Linvatec UltrAblator, Lightwave* K030720, K050923 Arthrex OPES* K023986 ValleyLab Electrosurgical Device K861112,K051627 Vanguard Medical Concepts ~ Reprocessed Arthroscopic Wands ~ K043198 Alliance Medical Reprocessed Soft Tissue Ablators ~ K012631… | 2005 |
| * | K043198 | Vanguard Reprocessed Arthroscopic WandsSummary page 1…rAblator, Lightwave* K030720, K050923 Arthrex OPES* K023986 ValleyLab Electrosurgical Device K861112,K051627 Vanguard Medical Concepts ~ Reprocessed Arthroscopic Wands ~ K043198 Alliance Medical Reprocessed Soft Tissue Ablators ~ K012631 Devices are monopolar and bipolar electrosurgical electrodes design… | 2005 |
| * | K012631 | Reprocessed Soft Tissue AblatorsSummary page 1…alleyLab Electrosurgical Device K861112,K051627 Vanguard Medical Concepts ~ Reprocessed Arthroscopic Wands ~ K043198 Alliance Medical Reprocessed Soft Tissue Ablators ~ K012631 Devices are monopolar and bipolar electrosurgical electrodes designed for ablation, resection and coagulation of soft tissue. In… | 2001 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 12 years and passes through 6 companies; a new generation was cleared every 1.1 years on median.
- 7 of the 93 ancestors have a recall of any class.
- 2 other devices also cite its predicate K033257.
How does its category compare?
All NUJ devicesNUJ Electrosurgical, Cutting & Coagulation Accessories, Laparoscopic & Endoscopic, Reprocessed: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · NUJ
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · NUJ
88in 2018
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · NUJ
11in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · NUJ
38in 2025
MAUDE reports naming product code NUJ, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 4 |
| 2008 | 1 | — | 2 | 4 |
| 2009 | 0 | — | 0 | 1 |
| 2010 | 1 | — | 0 | 9 |
| 2011 | 2 | — | 0 | 2 |
| 2012 | 2 | — | 0 | 39 |
| 2013 | 2 | — | 0 | 161 |
| 2014 | 1 | — | 0 | 74 |
| 2015 | 2 | — | 0 | 25 |
| 2016 | 5 | 155 | 0 | 52 |
| 2017 | 3 | 49 | 0 | 51 |
| 2018 | 7 | 88 | 0 | 14 |
| 2019 | 1 | — | 0 | 20 |
| 2020 | 0 | — | 0 | 59 |
| 2021 | 0 | — | 0 | 47 |
| 2022 | 2 | — | 0 | 31 |
| 2023 | 1 | — | 3 | 27 |
| 2024 | 1 | — | 0 | 92 |
| 2025 | 0 | — | 11 | 38 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
SureTek Reprocessed Electrosurgical Electrodes are intended for use during general, arthroscopic and endoscopic surgery for RF ablation, resection or coagulation of soft tissue and hemostasis of blood vessels.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K052692 · printed Nov 6, 2026
Cite this page
510(k) Report. “K052692: Suretek Medical Reprocessed Electrosurgical Electrodes.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K052692
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026